ID

31258

Descripción

A Comparative Study of Tramadol Hydrochloride Plus Acetaminophen Tablets Maintenance Versus Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Maintenance in Participants With Knee Osteoarthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00635349

Link

https://clinicaltrials.gov/show/NCT00635349

Palabras clave

Versiones (1)
  1. 4/8/18 4/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00635349

Inglés

Eligibility Osteoarthritis NCT00635349

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants who have suffered from knee osteoarthritis at least for one year and meet the criteria of american college of rheumatology
Descripción

Knee Osteoarthritis Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0872146
participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily or aceclofenac 100 mg twice a day at least for four weeks
Descripción

Meloxicam Dose Stable | Aceclofenac Dosage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0083381
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0050403
UMLS CUI [2,2]
C0178602
participants whose mean pain intensity has been 5 or higher on the numeric rating scale (nrs) for the last 48 hours
Descripción

Pain intensity mean Numeric Rating Scale

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1320357
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C4050142
participants whose general health conditions are favorable, according to the criteria below: medical and medication history, physical examination before the study medication administration, vital signs: blood pressure, pulse, clinical laboratory tests: serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvate transaminase (sgpt) less-than or equal to (=<) 2 x normal range, renal function: creatinine less than (<) 2.0 milligrams per deciliter (mg/dl)
Descripción

General health Favorable | Medical History | Medication history | Physical Examination | Vital signs | Blood Pressure | Pulse | Laboratory Procedures | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0424575
UMLS CUI [1,2]
C3640814
UMLS CUI [2]
C0262926
UMLS CUI [3]
C1553893
UMLS CUI [4]
C0031809
UMLS CUI [5]
C0518766
UMLS CUI [6]
C0005823
UMLS CUI [7]
C0391850
UMLS CUI [8]
C0022885
UMLS CUI [9]
C0201899
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0232804
UMLS CUI [12]
C0201976
female participants of childbearing potential to use the proper contraceptive methods during the study period (urine pregnancy test prior to the study participation should be negative)
Descripción

Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0430057
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who are applicable to kellgren and lawrence grade
Descripción

Study Subject Applicable Kellgren-Lawrence score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1706839
UMLS CUI [1,3]
C3177117
participants who had failed tramadol treatment before or stopped taking tramadol due to adverse event(s)
Descripción

Tramadol Unresponsive to Treatment | Tramadol Due to Adverse event | Tramadol Discontinued Due to Adverse event

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0040610
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0040610
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0877248
UMLS CUI [3,1]
C0040610
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0678226
UMLS CUI [3,4]
C0877248
participants who are applicable to one of the following conditions: rheumatoid arthritis, ankylosing spondylitis, active gout or active pseudo-gout, diagnosis of fibromyalgia (according to acr criteria), anserine bursitis, major trauma of the target joint within six months prior to the study medication administration, infection of the target joint within six months prior to the study medication administration, apparent avascular necrosis of the target joint within six months prior to the study medication administration, anatomical deformities of the target joint, which may interfere with assessment of the target joint, surgical procedures associated with the target joint within one year prior to the study medication administration, arthroscopic procedures associated with the target joint within six months prior to the study medication administration
Descripción

Rheumatoid Arthritis | Ankylosing spondylitis | Gout | Pseudogout | Fibromyalgia | Anserine bursitis | Major injury Target Joint | Communicable Disease Target Joint | Avascular necrosis Target Joint | Anatomical Deformities Target Joint | Interference Assessment Target Joint | Operative Surgical Procedures Associated with Target Joint | Arthroscopy Associated with Target Joint

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0038013
UMLS CUI [3]
C0018099
UMLS CUI [4]
C0033802
UMLS CUI [5]
C0016053
UMLS CUI [6]
C2005674
UMLS CUI [7,1]
C0332677
UMLS CUI [7,2]
C1521840
UMLS CUI [7,3]
C0022417
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C1521840
UMLS CUI [8,3]
C0022417
UMLS CUI [9,1]
C3887513
UMLS CUI [9,2]
C1521840
UMLS CUI [9,3]
C0022417
UMLS CUI [10,1]
C0302142
UMLS CUI [10,2]
C1521840
UMLS CUI [10,3]
C0022417
UMLS CUI [11,1]
C0521102
UMLS CUI [11,2]
C1516048
UMLS CUI [11,3]
C1521840
UMLS CUI [11,4]
C0022417
UMLS CUI [12,1]
C0543467
UMLS CUI [12,2]
C0332281
UMLS CUI [12,3]
C1521840
UMLS CUI [12,4]
C0022417
UMLS CUI [13,1]
C0003904
UMLS CUI [13,2]
C0332281
UMLS CUI [13,3]
C1521840
UMLS CUI [13,4]
C0022417
participants who have one of the following diseases: significantly unstable diseases such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, functional damage or disease which may cause malabsorption, excessive accumulation, or metabolism or excretion disorder
Descripción

Disease Unstable | Sleep Disorders | Sleep Apnea | Narcolepsy | Dementia | Damage Functional | Disease Causing Malabsorption | Accumulation Excessive | Metabolic Diseases | Excretion Disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0851578
UMLS CUI [3]
C0037315
UMLS CUI [4]
C0027404
UMLS CUI [5]
C0497327
UMLS CUI [6,1]
C1883709
UMLS CUI [6,2]
C0205245
UMLS CUI [7,1]
C0012634
UMLS CUI [7,2]
C0678227
UMLS CUI [7,3]
C3714745
UMLS CUI [8,1]
C4055506
UMLS CUI [8,2]
C0442802
UMLS CUI [9]
C0025517
UMLS CUI [10,1]
C0221102
UMLS CUI [10,2]
C0012634
participants who are pregnant or breast-feeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Osteoarthritis NCT00635349

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Knee Osteoarthritis Disease length
Item
participants who have suffered from knee osteoarthritis at least for one year and meet the criteria of american college of rheumatology
boolean
C0409959 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Meloxicam Dose Stable | Aceclofenac Dosage
Item
participants who are taking stable dose of meloxicam 7.5 milligram (mg) or 15 mg daily or aceclofenac 100 mg twice a day at least for four weeks
boolean
C0083381 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0050403 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Pain intensity mean Numeric Rating Scale
Item
participants whose mean pain intensity has been 5 or higher on the numeric rating scale (nrs) for the last 48 hours
boolean
C1320357 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C4050142 (UMLS CUI [1,3])
General health Favorable | Medical History | Medication history | Physical Examination | Vital signs | Blood Pressure | Pulse | Laboratory Procedures | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Renal function | Creatinine measurement, serum
Item
participants whose general health conditions are favorable, according to the criteria below: medical and medication history, physical examination before the study medication administration, vital signs: blood pressure, pulse, clinical laboratory tests: serum glutamic oxaloacetic transaminase (sgot)/serum glutamic pyruvate transaminase (sgpt) less-than or equal to (=<) 2 x normal range, renal function: creatinine less than (<) 2.0 milligrams per deciliter (mg/dl)
boolean
C0424575 (UMLS CUI [1,1])
C3640814 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2])
C1553893 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C0518766 (UMLS CUI [5])
C0005823 (UMLS CUI [6])
C0391850 (UMLS CUI [7])
C0022885 (UMLS CUI [8])
C0201899 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0232804 (UMLS CUI [11])
C0201976 (UMLS CUI [12])
Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative
Item
female participants of childbearing potential to use the proper contraceptive methods during the study period (urine pregnancy test prior to the study participation should be negative)
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Study Subject Applicable Kellgren-Lawrence score
Item
participants who are applicable to kellgren and lawrence grade
boolean
C0681850 (UMLS CUI [1,1])
C1706839 (UMLS CUI [1,2])
C3177117 (UMLS CUI [1,3])
Tramadol Unresponsive to Treatment | Tramadol Due to Adverse event | Tramadol Discontinued Due to Adverse event
Item
participants who had failed tramadol treatment before or stopped taking tramadol due to adverse event(s)
boolean
C0040610 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0040610 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
C0040610 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0678226 (UMLS CUI [3,3])
C0877248 (UMLS CUI [3,4])
Rheumatoid Arthritis | Ankylosing spondylitis | Gout | Pseudogout | Fibromyalgia | Anserine bursitis | Major injury Target Joint | Communicable Disease Target Joint | Avascular necrosis Target Joint | Anatomical Deformities Target Joint | Interference Assessment Target Joint | Operative Surgical Procedures Associated with Target Joint | Arthroscopy Associated with Target Joint
Item
participants who are applicable to one of the following conditions: rheumatoid arthritis, ankylosing spondylitis, active gout or active pseudo-gout, diagnosis of fibromyalgia (according to acr criteria), anserine bursitis, major trauma of the target joint within six months prior to the study medication administration, infection of the target joint within six months prior to the study medication administration, apparent avascular necrosis of the target joint within six months prior to the study medication administration, anatomical deformities of the target joint, which may interfere with assessment of the target joint, surgical procedures associated with the target joint within one year prior to the study medication administration, arthroscopic procedures associated with the target joint within six months prior to the study medication administration
boolean
C0003873 (UMLS CUI [1])
C0038013 (UMLS CUI [2])
C0018099 (UMLS CUI [3])
C0033802 (UMLS CUI [4])
C0016053 (UMLS CUI [5])
C2005674 (UMLS CUI [6])
C0332677 (UMLS CUI [7,1])
C1521840 (UMLS CUI [7,2])
C0022417 (UMLS CUI [7,3])
C0009450 (UMLS CUI [8,1])
C1521840 (UMLS CUI [8,2])
C0022417 (UMLS CUI [8,3])
C3887513 (UMLS CUI [9,1])
C1521840 (UMLS CUI [9,2])
C0022417 (UMLS CUI [9,3])
C0302142 (UMLS CUI [10,1])
C1521840 (UMLS CUI [10,2])
C0022417 (UMLS CUI [10,3])
C0521102 (UMLS CUI [11,1])
C1516048 (UMLS CUI [11,2])
C1521840 (UMLS CUI [11,3])
C0022417 (UMLS CUI [11,4])
C0543467 (UMLS CUI [12,1])
C0332281 (UMLS CUI [12,2])
C1521840 (UMLS CUI [12,3])
C0022417 (UMLS CUI [12,4])
C0003904 (UMLS CUI [13,1])
C0332281 (UMLS CUI [13,2])
C1521840 (UMLS CUI [13,3])
C0022417 (UMLS CUI [13,4])
Disease Unstable | Sleep Disorders | Sleep Apnea | Narcolepsy | Dementia | Damage Functional | Disease Causing Malabsorption | Accumulation Excessive | Metabolic Diseases | Excretion Disease
Item
participants who have one of the following diseases: significantly unstable diseases such as sleep disorder (e.g., sleep apnea or narcolepsy) or dementia, functional damage or disease which may cause malabsorption, excessive accumulation, or metabolism or excretion disorder
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0851578 (UMLS CUI [2])
C0037315 (UMLS CUI [3])
C0027404 (UMLS CUI [4])
C0497327 (UMLS CUI [5])
C1883709 (UMLS CUI [6,1])
C0205245 (UMLS CUI [6,2])
C0012634 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C3714745 (UMLS CUI [7,3])
C4055506 (UMLS CUI [8,1])
C0442802 (UMLS CUI [8,2])
C0025517 (UMLS CUI [9])
C0221102 (UMLS CUI [10,1])
C0012634 (UMLS CUI [10,2])
Pregnancy | Breast Feeding
Item
participants who are pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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